Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

NCT07792408 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: VX26-407-014
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Outcome Measures

Primary Outcomes (8)

• Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/EE in the Absence and Presence of VX-407

  From Day 1 up to Day 7 and Day 21 up to Day 27

• Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407

  From Day 1 up to Day 9 and Day 23 up to Day 31

• Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of NET and EE in the Absence and Presence of VX-407

  From Day 1 up to Day 5 and Day 19 up to Day 23

• Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of VX-407

  From Day 1 up to Day 7 and Day 21 up to Day 27

• Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG/EE in the Absence and Presence of VX-407

  From Day 1 up to Day 7 and Day 21 up to Day 27

• Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407

  From Day 1 up to Day 9 and Day 23 up to Day 31

• Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NET and EE in the Absence and Presence of VX-407

  From Day 1 up to Day 5 and Day 19 up to Day 23

• Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of DRSP and EE in the Absence and Presence of VX-407

  From Day 1 up to Day 7 and Day 21 up to Day 27

Secondary Outcomes (12)

• Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 up to Day 36

• Part B (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 Up to Day 39

• Part C (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 up to Day 32

• Part D (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 up to Day 36

• Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407

  Days 9, 15 and 21 up to Day 27

Study Arms (4)

Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)

EXPERIMENTAL

Participants will receive a single dose of LNG/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 every 12 hours (q12h) from Days 8 through 26 in fasted state.

Drug: VX-407; Drug: LNG/EE

Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)

EXPERIMENTAL

Participants will receive a single dose of NGM/EE on Days 1 and 23 in fasted state. Participants will also receive VX-407 q12h from Days 10 through 30 in fasted state.

Drug: VX-407; Drug: NGM/EE

Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)

EXPERIMENTAL

Participants will receive a single dose of NET/EE on Days 1 and 19 in fasted state. Participants will also receive VX-407 q12h from Days 6 through 22 in fasted state.

Drug: VX-407; Drug: NET/EE

Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)

EXPERIMENTAL

Participants will receive a single dose of DRSP/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 q12h from Days 8 through 26 in fasted state.

Drug: VX-407; Drug: DRSP/EE

Interventions

VX-407 DRUG

Tablets for Oral Administration.

Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE); Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE); Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE); Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)

LNG/EE DRUG

Combination Tablets for Oral Administration.

Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)

NGM/EE DRUG

Combination Tablets for Oral Administration.

Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)

NET/EE DRUG

Combination Tablets for Oral Administration.

Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)

DRSP/EE DRUG

Combination Tablets for Oral Administration.

Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2), inclusive
• A total body weight of greater than (\>) 50 kg

You may not qualify if:

• History of febrile illness within 5 days before the first dose of study drug
• Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Central Study Contacts

Medical Information

CONTACT

617-341-6777; medicalinfo@vrtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): March 20, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share